MAUDE Adverse Event Report: MAQUET SAS VOLISTA; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568811910

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue is being investigated by manufacturing site.

Event Description

On (b)(4) 2019 maquet (b)(4) became aware of an issue with one of devices- volista.As it was stated, the bracket is cracked.There was no injury reported however we decided to report the issue based on the potential as the crack may lead to the detachment of the cupola and then to the adverse event.(b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005 (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.According to the information provided by sales and service unit, the issue was found during performance of field action by (b)(4) technician.All three screws inside of the bracket were present but all of them were loose.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074 exemption # e2018005.(b)(4).Contact person: (b)(6).Maquet sas became aware of an incident with surgical light volista device.As it was stated, the bracket cracked.There was no injury reported as the failure was found during maintenance activities, nevertheless we decided to report the issue in abundance of caution as cracked bracket could lead to the detachment of cupola and to the adverse event.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.At the time when the event occurred the device was not being used for the patient treatment.During the investigation it was found that the occurrence rate for the issue of the light head shaft breaking is low (total of 12 complaints in the last 5 years of daily use of a large number of similar devices).The investigation was performed by product specialists at the manufacturer.It was established that the root cause of this incident is that a screw became loose at the junction location between the fork and the light head racket due to not enough efficient lock washer mounted during manufacturing process.The control process has been reinforced since january, 2016 and screws are pre-coated with glue to prevent to become loose.To sum up, the issue occurrence is due to manufacturing-man error.The affected devices are now being updated during field safety corrective action msa-2018-001-iu.The device involved in the event was found to be in the scope of mentioned fsca and action was performed on 25th february, 2019, therefore getinge does not propose any other action at this time.

• Brand Name: VOLISTA
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8390465
• MDR Text Key: 138215517
• Report Number: 9710055-2019-00056
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K130513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568811910
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 02/25/2019; 02/25/2019; 02/25/2019; 02/25/2019
• Supplement Dates FDA Received: 03/27/2019; 04/19/2019; 05/14/2019; 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1